remel BactiDrop Acridine Orange — Class II medical device recall Z-0266-2025
Ongoing recall by Remel, Inc, reported 2024-11-06, distributed in IL, IN, MN, NE, SD, TX, VA, WA. A color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in ou
| Recall number | Z-0266-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel, Inc, Lenexa, KS, United States |
| Recall initiated | 2024-09-20 |
| Classified | 2024-10-30 |
| Reported by FDA | 2024-11-06 |
| Distributed | IL, IN, MN, NE, SD, TX, VA, WA |
| Countries outside the US | GB |
| Quantity | 29 kits |
| UPC / GTIN / UDI-DI | 00848838000447 |
| Lot numbers | 733100 |
| Model numbers | 21502 |
| Expiration dates | 2025-04-04 |
Product
remel BactiDrop Acridine Orange, REF 21502, 50 per package.
Reason for recall
A color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0266-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.